Patient Controlled Propofol Sedation Versus Nurse-assisted Propofol Sedation in Diagnostic Colonoscopies With a Focus on Patient Satisfaction

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-90
SponsorKarolinska Institutet

About this trial

The goal of this clinical trial is to learn if patient administered propofol sedation results in superior patient satisfaction compared to nurse administered propofol sedation in diagnostic colonoscopies.

• Does self administration of the sedative propofol increase patient satisfaction? Researchers will compare patient administered propofol sedation (where the patient administers propofol by pushing a button) with nurse administered propofol sedation (where a nurse gives the patient bolus doses of propofol as deemed necessary)

Participants will:

* Be randomized to either sedation route. * Answer a preendoscopy questioneere and a postendoscopy questioneere 1 hour after the examination as well as one week after the examination.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Scheduled for elective diagnostic colonoscopy in propofol sedation

Able to understand the study information and provide inform consent

ASA I-II

Able to understand and use the patient-controlled sedation device

Disqualifiers

ASA >=III

Known hypersensitivity or contraindication to propofol or any excipient in the formulation.

Pregnancy or breastfeeding.

Inability to provide valid informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Self administred propofol

    Drug

    Patients will self administer propofol by pushing a button. When pushed a dose of 5 mg propofol will be given intravenously. The button can be pushed a maximum of 8 times per minute.

  • Nurse assisted propofol sedation

    Drug

    The endoscopy nurse will administer bolus dosus of propofol (10 mg iv) as needed during the examination

Treatment groups

135 Participants
are divided into 2 treatment groups
Group A: Patient controlled propofol sedationExperimental treatment 1 intervention
Group B: Nurse assisted propofol sedationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Patient satisfaction

Patient satisfaction measured using Patient satisfaction with sedation index (PSSI), a validated Likert-scale questionnaire with 13 questions. Each question with 5 ranks (1-5). Minimum score 13 , maximum score 65. Higher score indicates higher satisfaction with the sedation.

Time frame
One hour after the examination and one week after the examination

Secondary outcomes

1

Total propofol dose (mg)

Total given dose during the examination

Time frame
0 hours after examination
2

Recovery time

Time to patient is ready for discharge. Patient will be assesed every 15 minutes until ready for discharge, maximum 4 hours

Time frame
4 hours after the examination
3

Procedure duration

Time to completion of the procedure (min)

Time frame
0 hours after examination
4

Adverse events

Any adverse events related to sedation within 30 days

Time frame
30 days

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: